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Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

Sponsor
Maruho Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02066545
Collaborator
(none)
327
Enrollment
20
Locations
4
Arms
16.4
Patients Per Site

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with inflammatory acne vulgaris

Condition or Disease Intervention/Treatment Phase
  • Drug: CLS001 Topical Gel
  • Drug: CLS001 Topical Gel Vehicle
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
327 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Acne Vulgaris
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Vehicle Gel

Drug: CLS001 Topical Gel Vehicle
Experimental: CLS001 topical gel 1%

Topical application once daily

Drug: CLS001 Topical Gel
Experimental: CLS001 topical gel 1.75%

Topical application once daily

Drug: CLS001 Topical Gel
Experimental: CLS001 topical gel 2.5%

Topical application once daily

Drug: CLS001 Topical Gel

Outcome Measures

Primary Outcome Measures

  1. Change in inflammatory lesion count from Baseline [6, 9 and 12 weeks]

Secondary Outcome Measures

  1. Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions [1, 3, 6, 9 and 12 weeks]

  2. Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions [1, 3, 6, 9 and 12 weeks]

  3. Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit [1, 3, 6, 9, and 12 weeks]

  4. Percentage of subjects with a 2 grade reduction in the IGA at each visit [1, 3, 6, 9, and 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.

  • Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.

  • An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria:

  • Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)

  • Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)

  • Subjects with more than 2 facial nodulocystic lesions

Contacts and Locations

Locations

Site City State Country Postal Code
1 Encino Research Center Encino California United States 91436
2 Skin Surgery Medical Group, Inc. San Diego California United States 92117
3 Clinical Science Institute Santa Monica California United States 90404
4 Skin Care Research, Inc. Boca Raton Florida United States 33486
5 Belleair Research Center Pinellas Park Florida United States 33781
6 Moore Clinical Research, Inc. Tampa Florida United States 33609
7 Kenneth R. Beer, MD, PA West Palm Beach Florida United States 33401
8 MedaPhase, Inc. Newnan Georgia United States 30263
9 Hamzavi Dermatology Fort Gratiot Michigan United States 48059
10 Minnesota Clinical Study Center Fridley Minnesota United States 55432
11 Academic Dermatology Associates Albuquerque New Mexico United States 87106
12 Manhattan Dermatology & Cosmetic Center New York New York United States 10017
13 Derm Research Center of New York, Inc. Stony Brook New York United States 11790
14 Dermatology Consulting Services High Point North Carolina United States 27262
15 Wake Research Associates Raleigh North Carolina United States 27612
16 Tennessee Clinical Research Center Nashville Tennessee United States 37215
17 Premier Research Austin Texas United States 78705
18 J & S Studies, Inc. College Station Texas United States 77845
19 Progressive Clinical Research, PA San Antonio Texas United States 78229
20 Premier Clinical Research Spokane Washington United States 99204

Sponsors and Collaborators

  • Maruho Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maruho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02066545
Other Study ID Numbers:
  • CLS001-CO-PR-003
First Posted:
Feb 19, 2014
Last Update Posted:
Sep 17, 2015
Last Verified:
Sep 1, 2015
Additional relevant MeSH terms:
Acne Vulgaris

Study Results

No Results Posted as of Sep 17, 2015